Recall Z-1940-2016
Alcon Research, Ltd. · initiated April 28, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Codes / lots: Lot Numbers: 1785989H 1785990H 1786004H 1786005H 1786006H 1786007H 1791520H 1791521H 1791522H 1791523H 1791524H 1791525H 1791526H 1791527H 1791528H 1791529H 1791845H 1791846H 1793690H 1793706H 1793707H 1793709H 1793710H 1793711H 1793712H 1793713H 1793714H 1793715H 1793716H 1794101H 1794102H 1794103H 1794104H 1794105H 1794106H 1794107H 1794108H 1794153H 1794154H 1794155H 1794156H 1794157H 1794158H 1794159H 1794160H 1794161H 1794162H 1794163H 1794164H 1794165H 1794166H 1794167H 1794168H 1794544H 1794545H 1794546H 1794547H 1794548H 1794549H 1794550H 1794551H 1794552H 1794553H 1794554H 1794555H 1794556H 1794557H 1794558H 1794559H 1794560H 1794561H 1794562H 1794563H 1794564H 1794565H 1822927H 1822928H 1822929H 1794169H 1794175H 1794176H 1794566H 1794567H 1794568H 1794569H 1794570H 1794571H 1794572H 1796505H 1796506H 1799220H 1799221H 1799222H 1799223H 1799224H 1799225H 1799226H 1799227H 1799228H 1799229H 1799230H 1799231H 1799232H 1799233H 1799248H 1799249H 1799250H 1799251H 1799252H 1799253H 1799254H 1799255H 1799256H 1799257H 1799259H 1799260H 1799297H 1799333H 1799334H 1799335H 1799336H 1799337H 1799338H 1799339H 1799340H 1799341H 1799342H 1799344H 1799345H 1799346H 1799347H…
Reason for recall
Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
FDA-determined cause: Process control
Action taken
The affected consignees were sent a recall notification letter on 4/28/16.
Details
- Recall number
- Z-1940-2016
- Initiated
- April 28, 2016
- Posted by FDA
- June 9, 2016
- Terminated
- March 31, 2017
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 156,712 units
- Distribution
- US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey…
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX